Comparative bioequivalence study of Alprazolam 0.5 mg Tablet of Karen Pharma and Food Supplement Co. and Xanax® of Pfizer as reference in 24 healthy male under fasting conditions

Karen Pharma and Food Supplement Co.0 个研究点目标入组 24 人开始时间: 待定最近更新: 2023年5月1日

试验速览

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•Healthy subjects (male) between 20-45 years of age and Body Mass Index (BMI) within 15% of normal range values between 18.5-30 (inclusive), calculated as Kg/m2.
•Subjects with no significant diseases or abnormal findings during laboratory evaluations and clinical examination.
•Subjects with normal vital signs.
•Subjects who agree with patient consent form.

•Subjects with known allergy to the products tested.
•Subjects who have narrow angle glaucoma or are taking strong CYP3A inhibitors.
•History of cardiovascular, kidney, hepatic, muscular, metabolic, gastrointestinal (including constipation), neurologic, endocrine, hematopoietic (any kind of anemia), asthma, mental or organic disease.
•Subjects suffering from muscular trauma 21 days before the beginning of the study.
•Consumption of caffeine-containing products from 24 hour before dosing through 24 hour after administration.
•Any clinically significant illness during the 4 weeks prior to the first study drug administration.
•Hypotension (systolic blood pressure =90 millimeter Hg (mmHg) or diastolic blood pressure =60 mmHg) or hypertension (systolic blood pressure =130mmHg or diastolic blood pressure =90 mmHg).
•Smoking more than 10 cigarettes per day and could not tolerate cigarette cessation during each clinical period.
•Recent use of concomitant medication (prescription or over-the-counter) that could increase the risk of bleeding, or influence alprazolam pharmacokinetics.
•History of alcohol or drug abuse.
•Heavy drinker of caffeine, grapefruit juice or caffeinated drinks or who are on special diet (such as vegetarians) or do exertional physical activity.
•A history of difficulty with donating blood or donation of more than 500 ml blood within 7 days prior to the start of the study.

发起方

Karen Pharma and Food Supplement Co.